A “clinical trial” of foot bath “detoxification”

One of the most reliable indicators of a quack clinic that I know of (besides its offering homeopathy and reiki) is the inclusion of “detox foot bath” treatments on its roster of services. Detox foot baths, whatever the brand, are of a piece with other “detoxification” pseudoscience involving the feet, such as Kinoki foot pads. Basically, the idea is that you can some how remove toxins through the soles of your feet using either a nice mineral bath with a weak electrical current passed through it or a foot pad. Inevitably, nasty looking stuff is seen apparently coming out of the feet. In the case of the foot pads, it’s in the form of some sort of brownish black stuff on the pad; in the case of the footbath, the water turns brown. These color changes are presented as evidence that “toxins” have been pulled from the body through the soles of the feet, and those selling these devices make videos like this:

It’s all utter nonsense, of course. Indeed, “detox” foot pads and foot baths are among the very silliest treatments used in alternative medicine there are. First, the skin on the soles of the feet is thing and relatively impermeable, covered as it is with a layer of cells and keratin. But what about the color change? For the “detox footbath,” that’s easy. As I’ve described on more than one occasion, thanks to the minerals in the water and some basic physics and chemistry of electrolysis that lead to the corrosion of the electrodes, the water will change color whether feet are in the bath or not. Similarly, I’ve described how “detox footpads” turn black when exposed to warm moisture like steam (or like the bottoms of stinky feet). “Foot detox,” whether due to detox foot pads or detox foot baths, are a brilliant scam to bilk the gullible.

No wonder the merry band of antivaccine quacks and propagandists over at that wretched hive of scum and antivaccine quackery Age of Autism like it enough to advertise—get this!—a clinical trial of the IonCleanse System from A Major Difference (AMD). I’ve mentioned this system before and how AMD has jumped feet first (if you’ll excuse the term) into autism quackery. I learned of this “clinical trial” from AoA yesterday in this post about Therapy House LLC Clinical Trial Enrolling Participants in Pittsburgh for IonCleanse. I took a look at the protocol. Let’s just say that it’s not exactly rigorous, as you’ll see. First, however, see the genesis of this study. First AMD brags about having sold over 13,000 units in 39 countries, demonstrating once again that gullibility knows no nationality. Then, we learn:

In December of 2014, AMD was approached by The Thinking Moms’ Revolution to do a parent evaluation of the IonCleanse by AMD as it relates to children with ASD. The first of the 2-part study completed in April of 2015. This evaluation proved enormously successful and has paved the way for a wave of interest in the autism community.

Basically, from what I can tell, this “part one” was a single arm “study” (I really, really have to use scare quotes, because what TMR posted and a real clinical study are related only by coincidence), unblinded, with repeated measures. There’s nothing resembling a statistical analysis. I was half-tempted to show this post to one of our statisticians at the cancer center, but I decided that I didn’t want to cause harm by inducing relentless, unstoppable laughter that could cause her to pass out, particularly at the part that says:

The efficacy of treatments using ionic detoxification footbath technology has been validated through the TMR-ATEC Survey. Observed results, combined with mathematical analysis, have shown clearly that detoxification is an essential element in the autism recovery process.

And:

These results establish high confidence that continued use of the IonCleanse® Detoxification Footbath System can be used as an effective tool in the treatment of Autism Spectrum Disorder (ASD).

Um, no. It shows nothing of the sort. Moreover, this new study is not likely to show anything of the sort either. For instance:

Of the 30+ participants, 50% will be randomly selected to receive the IonCleanse by AMD sessions, and 50% will be part of the control group that will receive no therapy. Pre and post evaluations will be performed for all 30 participants, and the evaluators will be blind as to which children received treatment and which did not. The parents of the children and the children cannot be blinded as they will observe the water which may change color during actual therapy. The blinding of the evaluators as to the therapy/no therapy should be sufficient to assure a valid conclusion. Each patient will have total of 32 treatments. The pre-evaluation testing will be done within 7 days of beginning therapy and post-evaluation will be completed with 7 days of the last treatment.

After 60 days, success will be considered a significant reduction in ASD symptoms as determined by a repeat of the entry requirements assessment and a comparison of the treated patients to the control patients. For purposes of this study a greater than 25% overall reduction ASD symptoms will be clinically significant.

But how will this be determined? Thusly:

Data from the study will be collected at the study site, and provided to sponsor for data analysis. A simple analysis comparing pre procedure symptoms with post procedure symptoms will be performed, and a statically difference in measurement will be considered a success.

Let’s see. The bit about not being able to blind the parents or children is risible in the extreme, as it would not be that difficult to make a sham device that replicates the color change in the water in the control group. So, no, the blinding of the evaluators as to therapy/no therapy is not sufficient. Moreover, no study would ever pass institutional review board (IRB) muster (at least not with a decent IRB) without a decent plan for statistical analysis. Nothing resembling that exists here. Nor does anything resembling a plan to make sure that the two groups (control and IonCleanse) are comparable in terms of age, autism severity, comorbidities, etc., another very important basic part of any randomized clinical trial because if the groups aren’t comparable biases can creep in and affect the results.

Then there’s the issue of ethics. The common rule and federal regulations regarding the protection of human research subjects emphasize a higher standard to protect vulnerable populations, and children are a vulnerable population, particularly special needs children like autistic children. So what does AMD have to say about this? Not a lot:

The study is considered under FDA regulations as non-significant risk clinical trial. The trail will comply with FDA regulations by having the approval of a qualified Institutional Review Board.

Um, no. You don’t get to choose whether your study is a “non-significant risk” study. As the FDA points out, it is the IRB that determines whether a study is a “non-significant risk” study or not. I suppose I should be happy that this will be approved by an IRB, but given how antivaccine warriors like Mark and David Geier have set up their own IRBs to approve unethical studies, I’d be very interested in knowing what IRB AMD plans on using.

This study is a perfect example of what Harriet Hall likes to refer to as “Tooth Fairy science.” Basically, it’s doing research on a phenomenon before establishing that that phenomenon exists. As she likes to continue the analogy, you can measure how much money the Tooth Fairy leaves under the pillow, whether she leaves more cash for the first or last tooth, whether the payoff is greater if you leave the tooth in a plastic baggie versus wrapped in Kleenex. You can even get all kinds of good data that is reproducible and statistically significant. Yes, you think you have learned something. But you haven’t learned what you think you’ve learned, because you haven’t bothered to establish whether the Tooth Fairy really exists. In this case, it hasn’t been determined that these foot baths can pull toxins out of the body through the feet; quite the opposite, in fact. It also hasn’t been established that these unnamed “toxins” have anything to do with autism.

As I said early on, one of the surest indicators of quackery in a clinic is its inclusion of something like the IonCleanse foot bath. The purpose of this study isn’t really to determine efficacy or safety of the IonCleanse in treating autism. The design of the study virtually guarantees that it will find a positive result. That’s because it’s a marketing tool to produce more IonCleanse Ambassadors and sell more IonCleanse devices.

The bit about not being able to blind the parents or children is risible in the extreme, as it would not be that difficult to make a sham device that replicates the color change in the water in the control group.

Indeed.
Another idea, for people on a shoestring budget: have the foot-bather sitting at a desk with curtains covering their legs, and have the food bath being done out of their sight, under the desk. Rinse their feet with clean water once the foot bath is done, to mask any colored water.
Bonus, the patients can use the desk to read comics, play Rubik’s cube or whatever, to help pass time.

Heck, my mom, a housewife, could have set up such an the experience at home. It’s really cheap on resources.

50% will be part of the control group that will receive no therapy.

OK, so half the people get pampered to a nice, relaxing foot bath, the the other half got nothing. Did I get this right?
No possibility of bias here, not at all.

It also hasn’t been established that these unnamed “toxins” have anything to do with autism.

Neither do we know where these toxins are coming from.
If it’s from a vaccine, the doctor must have confused the 0.5 mL syringe with a big thermometer full of mercury. I mean, you can take 32 baths and the water is still getting brown – the amounts of toxins in your body must be huge.
I may even be tempted to bring a bit of logic and say that if you get this colored water with long non-vaccinated individuals, then it’s evidence that vaccines are not guilty of poisoning you – your normal lifestyle is doing a good enough job at poisoning you, as it is.

Observed results, combined with mathematical analysis

I was thinking Cargo Cult science, but Harriet Hall’s Tooth Fairy science is a much better descriptor.

Never heard of the “Battelle Development Inventory” before (bear in mind I used to do assessment for ASD and worked with one of the developers of the ADI), so I checked it out.

This – http://www.ncbi.nlm.nih.gov/pubmed/7686835 – came up as the first hit not from those selling the BDI…Hmmmm, nowhere near as well validated as the likes of the ADI and other standard assessment tools in common use here…Not filling me with any confidence there…

And, more importantly, it is NOT a tool for assessing ASD, rather a more generalist tool for looking at developmental issues, i.e. a bit too blunt for the task at hand.

Oh, and from your side of the Atlantic, some bods in Florida had this to say about the BDI (sorry, I struggle to use “BDI” when it doesn’t refer to the Beck Depression Inventory) – http://tats.ucf.edu/docs/eupdates/evaluation-8.pdf – which, significantly, includes the following passage:

Qualifications for Administering the Instrument
When administering an assessment, the knowledge, skills, and experience of the evaluator are an important part of the validity of the test and interpretation of results. In other words, in order to obtain accurate results, the examiner needs to understand the test well and should have a good understanding of typical and atypical child development.
The examiner must also understand and be comfortable with the age level of the child being assessed. “It is essential that examiners have appropriate training and experience working with the children of the age they will assess as well as comfort level that allows for easy interaction with them” (Battelle Development Inventory – Examiner’s Manual,
p. 10). If a young child with special needs is being evaluated, the examiner also should have sufficient knowledge of the disability and ways to provide appropriate
accommodations without compromising the results of the assessment.

This certainly raises a question, not answered, in the link to the “trial” details, about the qualifications and experience of those assessing the bairns…Yes, an OT is mentioned, but I see no mention of a psychiatrist, a paediatrician or a psychologist anywhere, nor of any decent experience in working with bairns on the spectrum (being a writer for AoA supports that view).

The bit about not being able to blind the parents or children is risible in the extreme, as it would not be that difficult to make a sham device that replicates the color change in the water in the control group.

That footbath looks pretty good to me and the explanation is really sciencey.
And I am impressed by the N-sizes. N=23, and an age spread of 2:13 years for the first study and a proposed 30+ (?),age spread unknown, for the second. We’re sure to get reliable, replicable studies here.

Orac, I think you should show the study to your statistician . Perhaps at the end of a hard week when the comic relief would be appreciated. Though, I suppose it could induce tears instead.

Why go after toxins in the feet? Well, we all know toxins are things like heavy metals, and it stands to reason that they would tend to settle in the lower extremities. It just makes all kinds of (non)sense.

In Hungary and likely elsewhere too they sell a “colon cleanser” called Colonix.
Apparently after you eat it it removes toxins and sediments/waste from the colon (that would otherwise cause – what else? – cancer). And you can see the removed toxins/waste in the toilet, which is apparently shocking.

In actuality, what you see in the toilet is of course the product itself – which contains guar gum in large quantities, as well as laxative to provide that emptied out feeling.

People buy this product all the time, I don’t understand how this and the foot bath with the toxin photos attached can be sold legally without a false advertising claim.

I could see a lot of IRBs giving this thing an okay, maybe with some minor recommendations for changes to the protocol (e.g., how to blind the subjects/parents, matching controls, etc.). However, this would not qualify for expedited review, since these types of footbaths have not received an FDA exemption (and, in fact, some products are barred from importation). AMD would have to have applied for, and received, an investigational device exemption prior to conducting this study.

I wonder if the FDA is aware of this. Perhaps some reporting is in order.

For clarity for those who may not know the regulations around medical devices, the Ion Cleanse foot bath, as it is currently marketed, is not considered a medical device, because it does not make any medical claims (just general, structure-function type statements akin to supplements). As such, FDA has not issued it either a Premarket Approval or 510(k) exemption.

Since they are studying its use as a treatment for autism, they would have to apply for an investigational device exemption, allowing them to use it in a study involving medical treatment. If they want to be able to market it for the treatment of autism, they would need to submit, at the very minimum, a 510(k) application, along with an explanation of why they think the device is Class I or Class II. Until they do so, any marketing they do claiming it can treat autism or reduce the symptoms of autism would likely be viewed as a medical claim in violation of FDA regulations.

and it stands to reason that they would tend to settle in the lower extremities

Well, that doesn’t explain the heavy metal accumulation in the brain which gives you autism, Alzheimer and whatnot.
Um, maybe people should stop doing handstands. Has anyone checked if there is a correlation between gymnasts and autism?
Or maybe our feet are our third brain, after the guts.

Something else missing from the protocol: Will the same device be used for the same subject at every session? Will a device be used for multiple subjects? How will the devices be cleaned between sessions to ensure no contamination occurs (e.g., I could see a fungal infection spreading from one subject to another if improper sterilization methods are not used)?

That TMR-ATEC “study” though. It’s cute how they think they’re doing science. Besides what Orac said about the lack of IRB and statistical analysis, there’s no methods, no references (beyond a few hyperlinks), no inclusion/exclusion criteria and no COI statement (but please note, AMD provided devices free of charge and participants were offered a 60% discount after the “study” ended).

There’s also no discussion of limitations, which hilariously seems to be a concept TMR doesn’t understand. Someone asked in the comments what the limitations were and the “Professor” replied “in what respect, Adam?”

The TMs had a 2 hour (!) panel at last year’s AutismOne Woo-fest ( which is possibly still available) wherein several of them raved about how well footbath ‘therapy’ improved their children’s scores on a test that measures autism.

How the ever-loving f*ck do they think blinding the evaluators is going to somehow make up for the fact that they haven’t blinded the kids or their parents? Of course the kids who think they’re getting a special “treatment” are going to act differently, and their parents are going to treat them differently, which will further influence their behavior. It’s like saying you could run an RCT on a new pain med without blinding the participants as long as you blind the researchers who evaluate their pain. Given how simple it would be to blind the kids and their parents, I can only assume this is a deliberate ploy to get the results they want rather than simple incompetence.

Ditto the small sample size and relatively wide age spread (2 – 8 years). With only 15 kids in each group, you can be sure they’ll be able to find a sub-group that shows a statistically significant response – of course, it’ll be sheer chance whether that response is positive or negative, but any subgroups whose post-treatment scores are lower can be dismissed, while those whose post-treatment scores are higher will be trumpeted as evidence their scam works.

It’s amazing to me that the same group of people who are so skeptical of studies that are funded by pharmaceutical companies (whether in reality or solely in their imaginations) are willing to participate in a sham “trial” that is so self-evidently nothing more than an elaborate advertisement.

With only 15 kids in each group, you can be sure they’ll be able to find a sub-group that shows a statistically significant response

It’s actually very hard to get a statistically significant response with a group size that small. The confidence interval for a group of size N is proportional to sqrt(N), so they would need a difference of about 8 to get a non-null result with 95% confidence.

That said, I agree that they are likely to claim a statistically significant response. They will achieve this via the usual method of torturing the data until it confesses.

Well, that doesn’t explain the heavy metal accumulation in the brain which gives you autism, Alzheimer and whatnot.

It is easily explained. These things (especially whatnot) are caused by Aluminum which is a lightweight metal and therefore rises to the head. But all is not lost. I am marketing a line of electrode equipped plastic pails that you can soak your head in.

“Also, why no chemical analysis of the foot bath after the alleged “detox”?”

Yep, and why not stop the bath early and check the skin on soles of the feet for these mystery toxins? They must be permeating/diffusing through the skin, and therefore should be detectable in the skin at fairly high concentrations while the bath is working its magic. You’d think that would be injurious to the skin on the soles of the feet.

Also, has anyone ever repeated the bath process immediately upon completion of a bath with new clean water? If the process works as advertised, at some point after x number of repetitions, you would expect to end up with nice clean water, just like when you repeatedly rinse out a dirty glass.

How does this magic process know to only remove the evil toxins and no vital nutrients? Just to be safe, should one take a multi-vitamin and some other supplements after a detoxing foot bath?

If only it were possible to detoxify with a footbath, my brother-in-law might not need 4+ hours of dialysis 5 days a week. #ItSucksHavingNoKidneys

Oy vey. Alt-med types criticize SBM doctors for offering one-size-fits-all treatments, and then they use devices like this which specify a “treatment” to be used by all with this condition.

Even if treating a condition by exciting certain vibrational[1] modes of certain molecules could work, why only ten? There are almost certainly more modes than that. How do they determine which modes are the “right” modes?

[1]This assumes, admittedly without basis, that a Rife machine operates in the relevant frequency range. I hope it doesn’t work on electronic modes, because those tend to require ionizing radiation for excitation.

Also, has anyone ever repeated the bath process immediately upon completion of a bath with new clean water? If the process works as advertised, at some point after x number of repetitions, you would expect to end up with nice clean water, just like when you repeatedly rinse out a dirty glass.

You would wouldn’t you? But the foot bath will always come out coloured (but you knew that didn’t you) as Ben Goldacre demonstrated with his ex-girlfriend’s Barbi Doll.

I don’t know chemistry (or any kind of science, tbh) so I have a question – is it even safe to stick your feet into that brown mess? It says it’s corroded electrodes, so I just wonder if that is something you should be submerging your feet in…
It would be kind of ironic if the foot bath did more harm than good.

I wonder that myself. Although it is not clear what kind of metal the electrolytes are, AMD’s site seems to imply it is stainless steel (at the very least some part of the electrolyte is stainless steel), which makes me a bit vary. Is there a chemist present? 😉

If any of these “professinals” knew what the foot baths were drawing out of the human body, they’d list specific substances instead of the catch-all of “toxins.” The term gets used to suggest that dozens of chemicals harmful to us are being removed (even though even water can be toxic in the right dose).

What gets me is that I’m 28, and I know way too many people that think this garbage works around my age. And those people are starting to have kids, and those kids will be raised under the illusion that this is real.

But they don’t need any chemical analysis, since they have these handy colour charts which tells them what they drew out.

And their color charts were validated how?

People who have done the experiment report that the water turns those colors if the foot bath is run without somebody’s feet in it. My guess is that the people who prepared those color charts don’t care whether it’s true or not.

As for the lack of specific substances: Remember, we’re dealing with people who are (perhaps but not necessarily by choice) ignorant of chemistry. That goes for both the sellers and the buyers of these products. Technobabble can be quite persuasive if you choose your audience right.

Data from the study will be collected at the study site, and provided to sponsor for data analysis

And who was the sponsor?

In December of 2014, AMD was approached by The Thinking Moms’ Revolution to do a parent evaluation of the IonCleanse by AMD as it relates to children with ASD. The first of the 2-part study completed in April of 2015. This evaluation proved enormously successful and has paved the way for a wave of interest in the autism community.

Whoo knows? I’ve just read about similar products and knew they usually come with a colour chart. And a quick look at IonCleaners page looked like they have those colour charts as well.

As with a lot of woo I’d expect someone have put a lot of thought into it without validating anything. Because it ruins the assumption that it works.

People who have done the experiment report that the water turns those colors if the foot bath is run without somebody’s feet in it.

I guess that’s why some of these machines uses a wrist strap. So the person getting ‘detoxed’ will not see the effect of the ‘detox’ (ie. rusty and toxic water) before they actually put their foot in the water.

Also, has anyone ever repeated the bath process immediately upon completion of a bath with new clean water? If the process works as advertised, at some point after x number of repetitions, you would expect to end up with nice clean water, just like when you repeatedly rinse out a dirty glass.

No, the toxins are homeopathic…yeah, that’s the ticket…homeopathic toxins in the kids, that get stronger the fewer there are, so you have to rinse them out even more…just keep rinsing (and buying foot bath solution)…

Children, especially children with developmental disabilities, are a protected population with a reduced capacity for consent. This would not in any reasonable world be an IRB Exempt study. Granted, these sorts think of their kids as defective possessions, so that is probably not important.

Probably. The color in the photos Orac has posted strongly suggest iron to me. Just what oxidation state the iron is in when it first enters the bath from the electrode will depend somewhat on what the electrolyte is. I’m guessing common salt. Iron(iii) chloride (ferric chloride) is water soluble and greenish yellow at low concentration. It is capable of dissolving many metals, but isn’t too hard on your hide. It tends to react with oxygen dissolved in the water, especially if the pH isn’t quite low, and ultimately yield a mix of iron oxides, which are brown to black and insoluble – suspended rust, which is harmless, though it might be a bit difficult to wash off.

If the electrodes are stainless steel, then you would also (i.e. along with iron) get nickel and chromium ions in the bath. Nickle cause contact dermatitis or “allergy” in some people. Certain chromium compounds are very toxic. Many stainless steel alloys contain small amounts of other goodies like molybdenum or manganese. If I were tasked with drawing up safety approval rules for something like this, I’d demand that the manufacturer prove that products of the electrolytic corrosion of the electrodes were safe.
Carbon electrodes would lose material from their surfaces, resulting in greying of the water, which would be much less impressive from the gullible user’s perspective.

The 1.9 amperes shown on the display in the still frame for the video is certainly enough to move metal reasonably rapidly from an iron-based anode into the electrolyte.

/////

Someone mentioned sampling the subjects’ feet to do chemical analysis. Try keeping the kids in the trial after their first close encounter with a skin biopsy punch – no local anesthetic permitted since it will be full of teh toxinz.

First, the skin on the soles of the feet is thing and relatively impermeable, covered as it is with a layer of cells and keratin… chemistry of electrolysis that lead to the corrosion of the electrodes, the water will change color whether feet are in the bath or not.

Ions can be induced to cross into the body transdermally. Depending on the e-field in that drink, I’d expect that there is actually some absorbtion of whatever is coming off the electrodes (looks like iron/steel). If they use copper electrodes, the water would turn a pretty blue.

After a nice and tingly footbath, one may dry that slurry out and make thermite with it just in case anyone has any cast iron welding to do or towers to drop.

The color of the water is not relevant, of course the ionized metals in the anode produces that, but with a little bit of curiosity it can be find uric acid in amounts easy demonstrable with an conventional urine test strip. After that, the real questions begin, how, how many or can it be somehow useful? Only objective curiosity for searching facts is needed.

If anyone is interested, the Canadian College of Naturopathic Medicine actually did a study on the IonCleanse footbath. It’s the only study listed on clinicaltrials.gov for the IonCleanse, and they actually published their results. Their conclusion?

Contrary to claims made for the machine, there does not appear to be any specific induction of toxic element release through the feet when running the machine according to specifications.

They actually tested the machine with and without feet, as well as collecting participants’ urine and hair samples to test for heavy metals.

If you are want to see how truly scientifically ignorant these people are, check out the comment thread between me, the Professor and another guy named Adam on the first TMR study page.

Such gems from the Prof as:

*I* CAN say these results are due to the IonCleanse and not placebo because I KNOW the people involved.

Addressing lack of placebo control:

It’s not hard at all to make a sham foot bath, but it’s a lot to ask of parents and children to take the chance of putting all this time into a sham protocol. I couldn’t do it, even for definitive scientific proof.

and

Yes, I am assuming the effect is due to the foot bath. YOU would need a control group to conclude that the effect was due to the foot bath. I, however, again, know the people involved, and there is no one intervention that created that much improvement in more than a handful of those children in the past.

In response to how she can claim the sample was representative:

The “criteria” I’m using is that I know the people involved in the study, and I know the autism spectrum. These children came from all over the autism spectrum and were both boys and girls.

The exchange between “ProfessorTMR” and two other commenters on the TMR blog has to be one of the funniest things I’ve seen:

Adam says:
July 22, 2015 at 1:36 pm
What are the limitations of this study?

Reply
ProfessorTMR says:
July 27, 2015 at 2:01 pm
In what respect, Adam?

Reply
capnkrunch says:
June 30, 2016 at 1:30 pm
Many papers discuss the limitations of the study’s methodology and how that affects what conclusions you can draw from it. Off the top of my head limitations for this study include:
-Single arm
-No controlling for confounders such as demographics and comorbidities
-Small and unrepresentative sample size
-Self (or rather parent) reporting; increases potential bias

A Limitations section for this might include something to the effect of “due to these limitations, efficacy can not be inferred from these results. However, it provides preliminary positive results that warrant further study.”

ProfessorTMR says:
June 30, 2016 at 2:22 pm
Yep, those limitations all exist. And that’s a great addition. Though, I think the “small and unrepresentative sample size” is not quite the limitation it may appear. I know the people involved, and it’s a pretty representative sample. In addition, the changes reported are so large that even with the smallish sample size, the null hypothesis (that the IonCleanse does not affect autism behavior) is extremely unlikely.

Adam says:
June 30, 2016 at 2:27 pm
How is it a representitive sample? What criteria are you using to conclude that?

Yes the effect size is there, but you’re assuming the effect is due to the foot bath, which is not a valid assumption given the study design. You would need a control group to conclude that.

ProfessorTMR says:
July 1, 2016 at 12:45 pm
The “criteria” I’m using is that I know the people involved in the study, and I know the autism spectrum. These children came from all over the autism spectrum and were both boys and girls. The only thing required for the study was an autism diagnosis. Children with seizure issues turned out to be bad candidates, but there were no other exclusion criteria.

Yes, I am assuming the effect is due to the foot bath. YOU would need a control group to conclude that the effect was due to the foot bath. I, however, again, know the people involved, and there is no one intervention that created that much improvement in more than a handful of those children in the past. The results of this study were absolutely, positively stunning. Good friends of mine got more excited than I’ve ever seen them. There is no possibility this was due to the placebo effect. The only way the result could be NOT due to the study is if every single one of those parents had encountered and begun the most effective intervention in their children’s lives all at the same time at the start of this study. Didn’t happen.

capnkrunch says:
June 30, 2016 at 5:55 pm
That may be true, but the paper includes no discussion of inclusion/exclusion criteria or how demographics were matched to make it representative. You can’t just claim it is without any evidence.

As far as sample size goes, you can’t make that claim about the without providing significance analysis. Also, because this is not placebo controlled you can’t say it’s due to the IonCleanse rather than placebo.

Lack of placebo controlls is a problem with the current study as well. It can’t be that hard to make a sham foot bath that just changes color or barring that, simply cover it so the child and parents don’t see what happens.

ProfessorTMR says:
July 1, 2016 at 12:26 pm
It was not meant to be a study done according to stringent scientific criteria to be published in the New England Journal of Medicine. To do so would have been significantly more difficult and expensive. It was meant to be a first cut at seeing what the IonCleanse can really do for children with autism, and it succeeded in that regard in spades. *I* CAN say these results are due to the IonCleanse and not placebo because I KNOW the people involved. Each of the families had done a great deal of biomedical treatment beforehand, with varying degrees of success. Improvement such as happened during the course of this study could have occurred without the IonCleanse in one or two of the children, but certainly not across the board like this. Several of the children involved made incredible breakthroughs, like learning to speak at the age of 12, and finally being able to potty train. These are not results that come about by accident. It’s not hard at all to make a sham foot bath, but it’s a lot to ask of parents and children to take the chance of putting all this time into a sham protocol. I couldn’t do it, even for definitive scientific proof. I would want each and every child who participated to have a shot of getting results like these.

Good grief, that’s some serious ignorance of study design. Here’s what I want to know: how many children dropped out because they couldn’t (wouldn’t) handle the foot baths? I know that we’ve discussed that some people with autism have intense responses to sensory stimuli (sounds, touch), so how do they (the children) feel about the baths?

And maybe a more probing question: did any children drop out of the study? Or were some kids who hated the baths forced to stick it out? (Because another tenet of ethical human studies is that any participant must be allowed to quit at any time for any reason.)

Ahh, NH Primary Care Doc #58 — sutures or placebo in a study of the efficacy on various methods of treating stab wounds?

“ProfessorTMR” does sound really convinced of some type of results. Of course, the darkening water is hokey but there is something going into the feet; Electric current. And an exchange of ions. As something goes in one foot, something else will go out the other if only very weakly.

Since I was a kid, I’ve used ‘electric handles’ off and on. That is, an audio signal from a stereo amplifier passed through a transformer and into the body. One really has no choice but to ‘keep the beat’ using them. Depending on the amplitude/frequency (voices hurt), the experience can range from pleasant muscle tensing to down right clamping the diaphram down scary (the safety is a thin piece of wire where one must only fall away from the device if one gets inadvertantly ‘locked on’). There is a feeling of water running throughout one’s arms as the current also stimulates the arterial pulse.

I used to ‘work out’ with such a system with tin-foil handles. I’ve used all manner of modulation; filters, phase shifters, …, a variable DC bias current. One may really work up a sweat with them and there even seems to be some endorphine activation. Also, if one takes selenium then little crystals can be observed to form on one palm.

So what if these footbath people are really onto something? Just not the something as claimed but something? The electric handles set to music can be pleasant and is great fun at parties… What if it could it could also be great therapy for autistics? Given the fun, I don’t see how it could be detrimental.

I know that we’ve discussed that some people with autism have intense responses to sensory stimuli (sounds, touch)

Interesting, JustaTech #59. The electric handles certainly are a burst of stimulation and mimics whatever the audio signal is. The amplitude control is simply the volume knob. If the kid doesn’t immediately reject the sensation then perhaps it may serve as ‘innoculation’ against overstimulation???

I had a look at the mfr’s web site, hoping for some better photos of the electrode array. Their design differs from that in the paper Todd cited. It looks like all metal components are stainless steel, arranged with four cathode plates interleaved with three anode plates. The design is such that almost all of the current would be “contained” within the volume of the plate array and there would be very little potential gradient measurable more than a few centimetres away from the limits of the array. This would optimize the rate of corrosion of the plates and minimize any possibility of have any effect on feet in the tub. It is possible to come up with a design with less chance of impinging current on the feet, but you’d have to work at it a bit. (I suppose you could put the feet in one pan of water and the electrodes in a bucket nearby, sort of in the manner of what’s-his-name, the Nobel laureate who was doing the homeopathy nonsense.) I can’t imagine the thing creating a potential gradient between epidermis and subcutaneous tissues of more than a few millivolts – and at that, probably only in the big toes and not necessarily of the “correct” polarity. A hybrid of this and Mil Ag’s head bath might work.
If I were ambitious, I’d cobble up a replica and do some tests. I ain’t ambitious.

The design is such that almost all of the current would be “contained” within the volume of the plate array and there would be very little potential gradient measurable more than a few centimetres away from the limits of the array.

My friend did massage at one of these places with the foot detox. While waiting for her to massage a client, I asked for a foot bath. I took my feet out as soon as they left me alone in the room. The water turned brown without my feet in it. They didn’t charge me…

I wanted to add comment to one of your June 2009 posts -The Caduceus represents the Guinea worms. When the worms mature and exit the human body, witch doctors would wind them around a stick to remove them. Archeologists/Anthropologists have found evidence of Guinea worm in mummies.

How does knowing the people involved account for the placebo effect? How does knowing them rule out the possibility that parents were looking for improvements in their children (even subconsciously) on the subsequent ATEC tests? Wouldn’t it be better to give some sham foot baths in order to reliably determine if the effect is caused […]

I know the people, and I know how they react to things. I’ve watched them react to OTHER interventions in the past, and they are ALWAYS looking for improvements but rarely finding more than a little improvement. TMR’s deadpan Brit took to writing status updates with 20 exclamation points. You don’t see that sort of thing and not KNOW you are dealing with something amazing. You don’t know me, so unless you’ve been reading our stuff for a long time, you can’t know that I tell the whole truth when it comes to interventions. I have repeatedly in the past said there is NO intervention that “works” (gets big results like these) for every child. And that is absolutely true, but if I were to suggest ONE intervention, with the exception of diet change (and there is no single diet that works well for everyone), this is the single best intervention I have seen. Hands down. It stands to reason because toxicity is the major problem we are dealing with. Having an easy reliable way to detoxify our kids’ bodies is a no-brainer. I have wanted one of the foot baths since they started the study, but my children do not have autism diagnoses and so we did not qualify. AFTER the study, I coveted a foot bath that much more because I know what a difference it made to my friends’ kids lives.

A Major Difference came to us to do their study because they knew that, as a prominent group of autism moms with a reputation for integrity, if their devices were helpful for our children, we would get the word out. In hindsight, it was the smartest thing they could possibly have done. The group of parents involved in the study were well-known to each other and all good friends. Imagine for a moment that the study participants were your family members, and they all needed a tremendous amount of healing to begin to function in the world. They all got approved for a promising new treatment that you’ve heard is saving lives. Would you be okay with only half of them getting the real thing while the other half didn’t, even though they might die if they don’t get it? It’s like that for us. These people are our extended family. Their kids are in dire need of effective interventions as the list of things they may never get to do grows day by day. You may think it’s more “ethical” to deny them treatment, but I cannot agree.

Each of the families had done a great deal of biomedical treatment beforehand

, which leaves me wondering if the apparent improvement in the kids is because innocuous, possibly even pleasant footbaths have been a respite from some of the horrible “biomedical” crap that actually was setting the kids back. Time spent having a footbath is time spent not getting a bleach enema.

it can be find uric acid in amounts easy demonstrable with an conventional urine test strip.

I’m not sure a conventional urine test strip is meant to detect uric acid in a sea of rust. The iron may add its touch of color to the strip..

Conventional urine test strips like the ubiquitous Multistix 10 SG don’t qualitatively or semi-quantitatively measure uric acid at all. A very quick google didn’t turn up any source of uric acid test strips. Not sure what that comment was about.

Sorry about the poor formatting; I’ve been reading RI for years but almost never comment, maybe I’ll get around to learning the tags someday…

A very quick google didn’t turn up any source of uric acid test strips.

I was wondering about this and searched, too. I found a number of colorimetric/enzymatic test kits, and there are test strips for uric acid as well (try “uric acid test strips”). It’s apparently aimed at people with gout, and is somewhat quantitative.
Um, now that I’m looking again, these strips seem to be intended to detect uric acid in blood, not urine (as I assumed, too). Not sure anymore if iron ions are going to be an issue.
I still don’t know how reliable these advertised strips are at doing quantitative work outside of biological fluids.

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For quoting, try to precede the quoted part with “Blockquote” put between the “less than” and “more than” signs. Don’t forget to close the caption with the same command preceded by a slash: “/Blockquote”

IIRC her kids don’t have ASDs and are NOT vaccinated
( see her bio on TMR/ ‘getting personal for the first; I learned about the second because I watch HOURS and HOURS of TM videos posted at 2015 Autism One./ not sure which one)

She is TMR’s so-called editor.

I don’t totally understand why she is so involved but I’m sure if leafed through the DSM5 I’d think of a few possibilities.

The Prof. may not be as stupid as she comes on. I’m thinking she might be getting a commission on every IonCleanse sold to a TM. The IonCleanse isn’t unique. There are other ‘ionic foot detox machines”. An IonCleanse ‘home unit’ runs just under $2K, but you can pick up a ‘basic’ ion footbath machine on eBay for under $100, with spiffier high-techy looking units only a bit higher. There are any number of sellers, but (for amusement only) here’s one eBay store that’s s sort of one-stop-woo-shop, with a 99.8% feedback rating: http://tinyurl.com/ht2x4bk

Anyway, this suggest the IonClense price includes a LOT of margin, and the company could easily give TMs a ‘discount’ pay a several hundred dollar ‘finder’s fee’ per sale to someone like The Prof., and still make out like, uhh, bandits. And The Prof. does wax at length about how well she knows the people involved…

It’s too bad no one has posted a query on TMR as to why they’re doing a ‘clinical trial’ only with the very pricey IonClenase, and not including, say, the $109 Cell Spa® Ionic Footbath Detox Machine. If the two are equally effective at reducing symptoms evaluated from pre-treatment to post-treatment, certainly the TMs would welcome a scientifc validation of that. If IonCleanse is confident it’s product is unique in the benefits it offers as an autism treatment, certainly it would welcome the opportunity to demonstrate that scientifically. And there’s your double-blind control. The Cell Spa® and the IonCleanse both make the water change color, so instead of a no treatment group, just have an IonCleanse group and a Cell Spa® group, each blinded to which machine is hooked-up to the footbath, and evaluated by clinicians who don’t know which patient was in which group. No sham bath needed.

Isn’t this sort of clinical trial on-point and easy enough to do? If it was suggested to the TMRs, it might generate enthusiasm form the rank-and-file, and it would offer some ‘fun’ in seeing how The Prof and IonCleanse would attempt to weasel out of it.

this suggest the IonClense price includes a LOT of margin, and the company could easily give TMs a ‘discount’ pay a several hundred dollar ‘finder’s fee’ per sale to someone like The Prof., and still make out like, uhh, bandits.

Ah, the old “big discount” gambit.

“And now, just because it’s you, I’m knocking 75% off the price!”

To show how naive I could be, it took me decades to realize that, since the guy offering the discount was the one who set the price in the first place, this gesture of generosity is meaningless. Tripling the price before publicly halving it still results in a comfortable benefit…

AFAIK they haven’t ever claimed that anyone is getting a commission or suchlike,
I just looked over some of their posts about IonCleanse. I’m sure I read somewhere how they got the devices but right now, I can’t recall (JEEEEZ I feel like I’m being questioned in a court ) They may have been provided for free.

In other news…
Mike Adams ( Natural News) declares today that the US is ” no longer a country of laws”
so I guess that means that he intends to libel SBM supporters and lie about research as much as is humanly possible without fear of retaliation.

@Box Turtle Yes, the electrodes have to be replaced. I think those for the bath Orac refers to are “good” for about 50 uses. The electrode assembly that appears in the still frame of the video that Graham (thanks, Graham – it showed pretty much just what I would have expected) posted is a different style, which, unfortunately for you, is available from a bunch of vendors on ebay.

I wonder if a spa (typo’d that as “sap”) running a bunch of these things on a daily basis would run afoul of toxic waste disposal regulations in some places, primarily due to the chromium they would be dumping.

I love how “ProfessorTMR” explains away the lack of a control group by making it sound like this is a year-long clinical trial of a medication that makes cancer cells literally disappear from inside the body, instead of a sixty-day “trial” of something that, if it truly is as miraculously effective as they claim, will be just as miraculously effective sixty days later.

Not to mention, they claim that there WAS a control: fifteen kids who received nothing at all. So the Prof there apparently *was* comfortable giving fifteen kids nothing at all (despite his/her claims otherwise), but was not comfortable giving those fifteen kids regular, non-“ionic” foot baths? Really?

I agree with Doug’s July 1 comment: those kids probably showed improvement because time spent having a lovely relaxing foot bath is time not spent having bleach pumped into one’s insides, or one’s veins punctured and fed chelation chemicals, or one’s skin burned, or whatever other forms of torture these people regularly inflict on their poor children. Who doesn’t feel better after a nice foot bath? Isn’t it possible that the effects of the foot bath were so soothing to the children that it made them calmer and more receptive in general? Or maybe even that it served as some sort of distraction/white noise to block out whatever else is in their heads, so they were better able to hear and pay attention to their parents etc.?

Honestly, I think that’s rather sad: Instead of advocating things like soothing foot baths as a way to make your child feel good, to bond with them, and to make them relaxed and comfortable enough to be more receptive to speech, touch, or play therapy, they’re attributing whatever success they found to “detoxifying,” which will only encourage parents (especially those who cannot afford $2k foot baths) to try more and wackier/more dangerous “detox” programs, instead of just spending more time sitting peacefully with their kids, talking to them, etc.

AMD provided them at no cost for the “trial” and participants were offered them for 60% off (SUCH DISCOUNT! WOW!) after the “trial” ended. At least for the first one; it says so in the blog post. Not sure about the second and don’t care enough to check but I assume it’s a similar deal.

Sheesh, Denise. I wasn’t suggesting IonCleanse was selling the units to the ‘trial’ participants, or that The Prof. was getting a cut above board. There’s no reason for AMD to do the ‘trial’ except to open/expand sales to ASD parents. Once the ‘trial’ reaches it’s positive conclusion, they’ll be marketing the machines to the TMRs. They’ll probably include some BS about how the InCeanse has some special technology other ion detox footbaths (at any price) don’t, only the IonCleanse has been proven as an ‘autism intervention’, and hint the two are linked, so if the TMRs want to relieve “the blight” only an IonCleanse will do. Then the market will be all the TMRs, not just the few in the limited geographic area who will participate in the study. I’s look for a ‘special discount’ to be offered to anyone who buys through TMR. 60% of 2K is $1200, and if the Chinese can sell a machine for $110, they probably cost about 75$ to make (max). So AMD can still make a huge profit with a 60% TMR discount, and kick $100 or so as a spiff back to The Prof. on each sale through TMR or referral.

Detox Hot Tub: “Salt water” swimming pools and hot tubs use electrolysis of brine, just like the foot baths, for chlorination instead of using gaseous chlorine. The electrodes are something “exotic” so they don’t corrode, since most people would find a pool filled with cloudy brown water rather unappealing. And of course pools are rather careful to avoid applying an electric field across patrons.
As far as I’ve been able to find, the hydrogen generated in swimming pools is just allowed to find its own way out.

A pool I cycle by occasionally has a back door labeled “CO2 Room”. Fizzy water pool, I guess.

Credit where credit is due; this is a really clever scam. Someone must’ve thought long and hard to come up with it. For the unitiated it really does look like your feet a producing toxic sludge from a mere footbath!

Just hope the customer/sucker never accidentally run it without their feet in, as that would produce the exact same sludge.

Amethyst @100: I see these all the time at big shows (fairs, marathon conventions, any place with lots of vendors) and I always wonder how they manage to not get a bath to go “off” while they’re waiting for another sucker to come by.

(Also, who wants to then walk the rest of the event in slightly damp socks?)

Anyhow, as far as fairs and conventions go, I bet they use mock devices without any metal parts in them if they have a footbath or two running for demonstration purposes? When someone is invited to try, they probably make up some excuse to replace it for the real deal.

I was skeptical at first when I came across an ion cleanser. However, I will tell you that after 6 months to a year of using the device, I no loner have allergies, hemorrhoids, tennis elbow, varicose veins have diminished (still visible in some areas) but they are not as bad as they were. With all of this issue that I have been having most of my life, the only thing that I have done differently was use the ion cleanser. I was not planning on, or have any idea that any of these issues would get better from the cleanser. You can call it what every you want based on your research. I am calling it great from experience.

Why did it take you almost four months to figure out that you no longer have those complaints? My guess is that the fancy foot bath made you very slow at typing on your keyboard. Also you do not that understand your “experience” (also known as an “anecdote”) is not real evidence.

I don’t see the need to be antagonistic about my experience with the cleanser, but maybe that’s what you respond to, so I’ll return the sentiment.. From the top, Chris, the definition of experience is: practical contact with and observation of facts OR events – just to jog memory. The coloration I made between putting my feet in the foot bath was MY experience. I didn’t write ‘real evidence’ in my post, so where are you getting that from hoss?. herr, the time line of 6 to 12 months should have been; I notice a difference after six month, and I’ve owned the device for 12 months. So, my memory is fine, how’s your head feeling? Adderall withdrawals? Last, Bacon, true that did sound like an advertisement, I agree with you there, but that’s about it. What’s worse, dangerous bacon or sugar?? Anyway, either the cleanser had something to do with my four issues that I listed previously, or they did not, and they got better on their own. How about this, I stop using the device, and see if the problems come back, and then go back using the cleanser, and see if they go away again. Could you three amigos wait in suspense that long? I guess that’s just not enough real evidence huh Chris. Regardless that is my experience with the ion cleanser. I don’t sell them. I don’t care if you believe me or not. I would however, elect that you not purchase one, because I’d rather see the drug companies increase their profits off of your ignorance.

Again, Mr. Chris, you don’t have to believe the connection. However, my ailments got better during the time I started using the cleanser. I BELIEVE there is a correlation. For example, the other day when I used the cleanser, it was very red. I have never seen the water that red before. What changed in my life? Hmm…My intake of beats that’s what. But there is no way that is coming out of my feet according to you people. Can you enlighten me on this one, or better yet, provide a “Newsflash”. Maybe that red color could be evidence that toxins dyed in red beat juice are coming out of my feet?

Mr. Chris, this webpage has done a poor job offering quantifiable measurable facts totally debunking it..using words like “utter nonsense” that is a scientific term right? Oh and I like this one “the skin on the soles of the feet is thing and relatively impermeable” Who writes this stuff? This is a science website, right? You’re an insightful bunch with your profound comments.

I’ll try this yet again. Four ailments were troubling me before the cleanser came into my life. Those four ailments are now gone. Now lets go over the definition of the word evidence: the available body of facts or information indicating whether a belief or proposition is true or valid. My experience is evidence enough for me.

“skin on the soles of the feet is thing and relatively impermeable”

So, relatively impermeable…but It been said that if you rub fresh garlic on the bottom of your foot, you will taste the garlic in your mouth within 15 minutes, demonstrating the fact that what you put on your skin circulates everywhere in your body. Science fact or, help me Chris, or you Narad.

Good question and it shouldn’t be enough for anyone else. This is a personal account of using the device. That’s it. Maybe I can write an equation with some unknown variables to make this sound more scientific. Again, I’ve stated that these people do not have to believe my testimony. However, take my experience and people with other similar experiences, and start compiling your data (stories if you talk to chris) and draw your own conclusions. Think about it, if this device was considered medicine that cured say a headache, then the FDA would come in and stop the whole thing, because “they” say what is and what is not medicine, based on their science. Historically, the FDA has required new drugs undergo expensive and elaborate multi-phased clinical trials, which are out of the grasp of any ordinary interest who might want to demonstrate the efficacy of a non-patentable herb, food or FOOT BATH. There’s no money or the evidence you are looking for in natural remedies. Just positive results.